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Safety & PV Ops Specialist II (ARGUS / Veeva) | Syneos Health | Pune
Syneos Health
Safety & PV Ops Specialist II (ARGUS / Veeva) | Syneos Health | Pune
Hiring Safety & PV Ops Specialist II at Syneos Health, Pune. Life science graduates with ARGUS or Veeva Safety experience preferred.
Syneos Health, a global biopharmaceutical leader, is seeking an experienced Safety & Pharmacovigilance Operations Specialist II – Technology Support (ARGUS Console or Veeva Safety preferred) to join its dynamic team in Pune, India. This role offers the opportunity to contribute to life-saving drug safety initiatives, collaborate across global teams, and advance your career in pharmacovigilance technology support.
Company Overview
Syneos Health® is a leading integrated biopharmaceutical solutions organization with a mission to accelerate customer success and improve patient outcomes worldwide. Operating in over 110 countries, Syneos Health combines clinical development, medical affairs, and commercial expertise to bring life-changing therapies to market. The company partners with 94% of novel FDA-approved drugs and 95% of EMA-authorized products, demonstrating its global influence and credibility in the pharmaceutical industry.
At Syneos Health, employees are encouraged to innovate and challenge the status quo while being supported through professional development, inclusive culture, and total rewards programs. Their “Total Self” culture fosters authenticity, belonging, and collaboration among over 29,000 employees worldwide.
Job Role & Responsibilities
As a Safety & PV Operations Specialist II – Technology Support, you will play a critical role in maintaining pharmacovigilance (PV) systems and ensuring regulatory compliance for global safety operations. The position involves technical expertise in ARGUS Console or Veeva Safety platforms and close collaboration with cross-functional teams.
Key Responsibilities:
- Assist in managing and maintaining the global safety database systems (ARGUS / Veeva Safety), including user setup, configuration, upgrades, and data migration.
- Perform MedDRA and WHO Drug Dictionary updates and ensure database compliance with regulatory reporting standards.
- Develop, update, and maintain Job Aids, SOPs, and technical documentation for PV systems.
- Generate, validate, and maintain safety reports, listings, and queries for internal, client, or regulatory use.
- Support ongoing safety data migration and validation activities, ensuring data accuracy and completeness.
- Participate in project and cross-functional meetings, providing system support and pharmacovigilance insights.
- Maintain compliance with FDA, EMA, and ICH guidelines for drug safety and pharmacovigilance operations.
- Manage system performance qualification (PQ) testing, routine patch updates, and validation activities.
- Support Syneos Health’s global pharmacovigilance initiatives by ensuring robust technology support and regulatory alignment.
Eligibility / Qualifications
Educational Background:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related technical field.
Experience Requirements:
- 2–5 years of experience in pharmacovigilance operations, safety database management, or regulatory systems.
- Prior hands-on experience with ARGUS Console or Veeva Safety systems is highly desirable.
- Excellent knowledge of ICH, FDA, and EU pharmacovigilance guidelines.
Technical Skills:
- Strong command of Microsoft Office Suite (Word, Excel, PowerPoint, Visio).
- Understanding of MedDRA, WHO-DD, and regulatory submission processes.
- Ability to manage multiple tasks, prioritize efficiently, and meet deadlines.
Soft Skills:
- Strong written and verbal communication skills.
- High attention to detail and documentation accuracy.
- Analytical mindset with problem-solving orientation.
- Proven ability to work independently and in global team settings.
Location & Salary
Location: Pune, India
Work Mode: Remote / Full-Time
Compensation: Competitive and based on experience. Syneos Health offers performance-linked incentives, health benefits, and continuous learning opportunities.
Application Process
Interested and qualified candidates can apply directly through the official Syneos Health career portal using the link below:
Ensure your resume highlights relevant experience with ARGUS or Veeva systems and pharmacovigilance expertise. Early applications are encouraged to secure priority consideration.
Why Join Syneos Health
- Collaborate with global pharmaceutical leaders and participate in breakthrough projects.
- Work on innovative technology platforms that enhance drug safety and reporting accuracy.
- Be part of an inclusive, diverse, and empowering workplace that values your growth.
- Access world-class training and certification programs in pharmacovigilance and regulatory affairs.
Career Growth Opportunities
Syneos Health is known for promoting talent from within. Employees in PV Operations roles can advance to Senior Safety Specialist, Safety Data Manager, or Global PV Technology Lead positions. The company provides structured learning pathways in:
- Pharmacovigilance Data Management
- Drug Safety Coding and Case Processing
- Safety Database Administration (Oracle ARGUS, Veeva Vault)
- Clinical Safety Operations
- Regulatory Intelligence and Compliance
Suggested Courses & Certifications
To strengthen your career prospects, consider certifications like:
- Advanced Pharmacovigilance and Clinical Research
- ARGUS Safety Database Training
- Veeva Vault Safety Certification
- ICH-GCP and Drug Safety Regulations
- Regulatory Affairs and Quality Compliance
These courses can significantly improve your chances of selection and help you excel in this specialized domain.
Frequently Asked Questions (FAQs)
1. Who can apply for this position?
Candidates with a degree in life sciences, pharmacy, or computer science and experience with ARGUS or Veeva Safety systems are ideal for this role.
2. Is this a remote position?
Yes, this is a remote full-time position based in Pune, offering flexibility for qualified professionals.
3. What kind of experience is required?
2–5 years of pharmacovigilance technology or safety database management experience is preferred.
4. What are the career growth options in Syneos Health?
You can progress into senior PV, data management, or safety system leadership roles with continued training and experience.
5. When is the last date to apply?
Applications are reviewed on a rolling basis. Apply soon to increase your chances of consideration.
Call to Action
Don’t miss this opportunity to work with one of the world’s top biopharmaceutical solutions organizations.
Apply now and contribute to global patient safety and regulatory excellence.
📅 Apply before positions fill up! Secure your place today.
Summary Table
| Company | Syneos Health |
|---|---|
| Vacancies | Safety & PV Ops Specialist II – Technology Support |
| Required Education | B.Pharm, M.Pharm, Life Sciences, Nursing, Computer Science |
| Experience | 2–5 years (ARGUS or Veeva Safety systems preferred) |
| Location | Pune / Remote |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.